Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing
mindhive.org
mindhive.org
As long as they lead to delivering to the public/govt. what is needed?
More like, one of the first vaccine-induced immunities. Regular survivors develop an immunity, after all.
> the researchers involved know what they are doing and would never push something like this if it weren't safe
No, they do all the time. They do not know if it's safe. They don't have enough indication that it's unsafe. There's a huuuge difference. That's what the trials are for: To find out if they're safe and work. Both assertions can only be made after the trials.
> I will be one of the first people in the world with an immunity against SARS-CoV-2
Millions already are.
Just read the papers you'll sign carefully so you don't go into all of this while not being 100% informed.
You might become one of the first. Not all people gain immunity from vaccines. That's one of the things that the phase 3 trial is designed to measure.
Good luck, though. We really need a working vaccine, pronto. Thank you for participating.
Safe modern medicine involves care and testing, that’s the whole point of organizations like the FDA. If we just carelessly push stuff like this through we can end up with some pretty nasty stuff.
Does this mean "no consent given for the medication" or "medication that is not part of an agreed consensus"?
If the former, then there are literally tons of occurrences of this everywhere.
I am also not sure of the implications that it entails. If I find someone injured on the street, and he tells me he does not want help, would it then be against the law for me to discard his instructions and help him?
Are there specific types of situations you're thinking about? Outside of cases where the patient is unable to provide consent (minority, mental incapacity, unconscious in exigent circumstances), I believe this is largely followed in the US, at least. Childhood vaccines, for example, are optional if you don't want to attend public (or many private) schools.
The whole point of rights is that they're non-conditional. That's why most western countries currently don't do any forced vaccinations (although some may deny certain government services to people who are unvaccinated). Without a strong commitment to human rights, there's nothing to stop the next racist dictator who comes along from sterilising ethnicities or political groups he doesn't like (as is allegedly happening in Xinjiang).
I agree with the broad point about the importance of the right to consent/ refuse treatment. But, surely, there can be places where individuals' rights conflict and society's tie-breaking creates conditions on the rights.
Freedom of religion as long as your religion isn't to sacrifice unwilling virgins.
Freedom of speech as long as what you want to say isn't to make false claims about the safety of your food product.
Rights are "unconditioned where possible" and where they conflict, it's an appropriate place for societies to debate their merits, metes, and bounds.
Extended to unwanted medical treatment... imagine Joe CRISPR'ed himself a gene that improved his eyesight, but also caused him to emit bromine gas that kills 90% of people who come within 100 feet of him. To date, Joe has killed thousands of people with his gas cloud. Society might rightly deem that he was infringing on their right to life and that that negative right was more important than Joe's negative right not to be forced into the reversing medical procedure.
Somewhere on the spectrum between "bromine gas cloud" and "germs for the sniffles", there's probably a condition Joe could have for which Joe's right to avoid unwanted medial treatment and society's right to not be needlessly kiled are really evenly balanced. Maybe it's ebola. Maybe it's covid... or measels, or the seasonal flu.
The right not to be forced into medical treatments is important and should be talked about, but to cast it as a right and therefore unconditioned and inviolate is to dodge the important societal debate.
Wouldn’t that require some kind of nuclear reaction/alchemy? I don’t think anything humans are normally exposed to contains bromine.
A strong commitment to human rights doesn't mean rights are non-conditional, so you're moving the goalpost to make a slippery slope argument. Anyways, laws are what can stop these things from happening. Yes, some laws go hand-in-hand with human(e.g. universal suffrage), some don't (e.g, conflicts of interest laws)
From the first line of the Universal Declaration of Human Rights (https://www.un.org/en/universal-declaration-human-rights/):
"Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world"
Note the word "inalienable".
Or if you don't like the UN, there's the US declaration of independence:
"We hold these truths to be self-evident, that all men are created equal, that they are endowed by their creator with certain unalienable rights, that among these are life, liberty and the pursuit of happiness. That to secure these rights, Governments are instituted among men, deriving their just powers from the consent of the governed. That whenever any form of government becomes destructive of these ends, it is the right of the people to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their safety and happiness."
The whole point of countries having a supreme court and constitution is to enforce the unconditionality of such rights.
Yes it's a political position held by some nowadays that human rights are just a legal fiction granted by the government or "society", but that's not how the nation's founders saw it.
Individual rights can (and IMO should) be abridged when it impedes on the greater good.
Even in a crises where scientist should be the shot callers, and regulators should be on their best game... no...
They became tools of politicians.
It's not only in the US. It's not just another "Trump thing". It's a worldwide phenomena. Every matter goes through the lens of politicians to get a refraction, or a twist.
Doesn't matter if it's a technical issue, or a scientific issue, that would required technical or scientific solutions - it all dilutes into politics.
The majority seems to be trying to leverage this pandemic for their political gains, even if that means cutting corners, hide or manipulate information. It's disgusting.
This is a broad statement and makes me think of how readily people talk about "fascism" and "neo-nazis" nowadays with little regard to whether the people they're describing bear any relation to Mussolini or Hitler.
Those were totalitarian states. Authoritarian is general term which can be used to describe any entity engaging in autocratic decision making.
You're responsible to the Constitution. Once you violate that you're arguably authoritarian. Blind submission to power without regard for protections against it...that's authoritarianism.
Eh, at least on vaccine approval, it... kind of is? The only cases I'm aware of are this one and the Russian one, and the Russian one was really more of a publicity exercise (they're 'approving' it, but only for very limited distribution, making it rather similar to a normal phase 3 in practice).
I think part of this is how the US govt is structured, rather than politics per se. It's particularly easy in the US for the executive to lean on government agencies; if nothing else it can get rid of heads of agencies without much fuss, whereas this would be anything from a major political scandal to just outright impossible in many developed countries. Also, of course, the executive is one person; in a parliamentary system this sort of leaning would require multiple people to make decisions that were, as Yes Minister put it, 'brave' (ie potentially career-ending).
Note that the worst long-term outcome of this was probably decline in trust of vaccines. Government regulators are in a position of significant trust on this stuff, and the consequences if that was damaged would be disastrous.
Realistic worst case: there are some minor complications, and some people will get hurt. This has happened before: https://www.cdc.gov/vaccinesafety/concerns/concerns-history.... , which is why we have such strict guidelines for vaccine development today.
Realistic bad case: the vaccine is not at all effective and does absolutely not protect from (re-)infection, but gives everyone post-covid19-fatigue. It will also be giving anti-vaxxers actual arguments and getting Trump re-elected.
> nearly 400,000 children had been inoculated with Cutter polio vaccine and 250 cases of atypical paralytic polio occurred. There were also reports of the Wyeth pharmaceutical company polio vaccine causing paralysis and death in several children in the northeastern United States. 19 , 21
> It was soon discovered that some lots of Cutter and Wyeth polio vaccine were insufficiently inactivated with formalin leading to live polio virus in more than 100,000 doses. In fact, 16 lots of Cutter polio vaccine were retested and the first six lots produced were positive for live polio virus. These incidents demonstrated the lack of oversight and safeguards put into place before the vaccine was made so widely available.
But yes, we should definitely be as sure as possible that the vaccine is reasonably safe and effective before getting into large scale vaccination campaigns.
Not because of the antivaxers though. Because it would be incredibly irresponsible not to do so and it could hurt many people.
CDC admits only 6% of reported COVID-19 deaths were actually caused by COVID.[0]
> Table 3 shows the types of health conditions and contributing causes mentioned in conjunction with deaths involving coronavirus disease 2019 (COVID-19). For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.6 additional conditions or causes per death.
If it works, praise the POTUS for being "brave", if it fails, blame the company.
Sure, the vaccine looks safe, and we might discuss if the protocol of Phase 3 testing can be modified and/or what are the reasons for it, but ignoring testing is stupid (and it's not only a matter of safe/not safe, but of dosage, booster shots required, etc)
Wear a mask and protect yourself while the vaccine gets ready, it's not hard. Or not, if you believe the recent misinformation news about "only 6% of healthy people die" then please join the queue for your Darwin Award.
Bioethicists who have forbidden challenge trials in vaccine trials have firmly taken the no-action stance in the trolley problem.
A normal phase 3 trial gives the vaccine to volunteers and waits for them to get sick (or not). A challenge trial is the same, but infects the volunteers intentionally, which significantly speeds up the trial and reduces the sample size needed.
The trolley is running over thousands of people every day, and by flipping a switch you could reroute it to another rail where only a few people would be at risk. The modern bioethicist stance is that flipping this switch is unacceptable. Maybe waiting for people to randomly fall ill instead of acting is more holy and sacred — or perhaps "natural".
Can you imagine what happens if the antivax crowd gains actual arguments? I don't want to.
Thalidomide changed our relationship with new medicines for ever.
It took five years for the connection between thalidomide taken by pregnant women and the impact on their children to be made. Not only did thalidomide change people’s lives, but it resulted in tighter drug testing and reporting of side-effects.
The mathematical issue is that a vaccine is given to everybody, so even if it has a very small rate of harm, it can be greater than the illness it's meant to prevent, if the incidence of the illness is small enough.
I'm not against vaccines in general, but they have to be incredibly safe to be worthwhile, assuming all lives are equal. Much more so than regular medication that is only given to sick people. Inherently, there has to be a higher bar.
The relatively known risks of some types of a vaccine seem a lot better than the unknown ones of COVID.
I would want to wait for full phase III before we had a mandatory vaccine, relied on this fully, or otherwise did too much with it. But we can't ramp up production that quickly regardless. A pilot with a few million volunteers seems as good as any phase III. And with the right few million, it could potentially really curb spread.
And some will quibble over the precise definitions of "vast" and "low" in that statement.
https://www.bmj.com/content/370/bmj.m2815
Plus, there's common sense. I live in an area hit by COVID hard. About half of the people who I've heard of catching COVID19 through friend networks have some sort of long-term effects. Most are minor, but a few are not. I think the question is what happens a few years out.
I would expect that would leave a trail in literature if it were the case.
Do you have a source for that?
As far as I'm aware they're both pretty low, but we haven't had a study that concluded what you're saying.
The Nature article has risk of death for 0-19yo at about 0%, while your graph has flu deaths at 0.01% for that group.
Which means the flu is more dangerous for kids than covid-19.
The Nature article has risk of death for 20-40yo at ~0.02%, same as your graph, so it's probably on par in that age group. Which means that my original point stands, if you're not scared of dying of the flu, you should not be scared of dying of covid-19.
Unfortunately, humans have some crazy biases when it comes to evaluating risk. We're very bad at weighing the risk of rare events (<1% probability), we tend to overestimate them, and we're extremely bad at weighing new and previously not encountered risks, we severely overestimate them. The same bias also causes us to underestimate known risks, which is why some people are afraid of flying, but not of driving to the airport, even though risk analysis says it should be the other way around.
And this is why people think covid-19 is super-duper scary, while no-one cares about the flu, even though for most of us we should value them about the same.
See: https://i.insider.com/5ef234caf34d051bc821d0d8?width=1000&fo...
"Because that disagrees not only with the common sense of seeing what is happening in front of us, but also with all the other evidence I've seen"
This statement suggests you haven't looked at (m)any scientific articles. I've read dozens of scientific articles about long COVID. If you posted a reasonable rebuttal to some of these, it'd be one thing. But simply stating you've never seen any evidence? That's a statement about your own level of knowledge, not about COVID19.
Aside from that, I do look at "that idiot's Twitter feed" from time to time. Your comments mirror the things he posts downplaying COVID19. Perhaps you look at secondary sources based on his Twitter feed? Or the same sources he does? I'm not quite sure.
As an aside, I'd advise everyone to read "that idiot's Twitter feed," much as I advise everyone to read international news source, left-wing news sources, and right-wing ones. You don't need to agree with someone to read what they write.
The chronology of this subthread goes:
1) You claimed that COVID-19 is 10x more likely to kill an under-40-year-old than the flu. To me, having read many scientific papers (they are my primary source of information about the current pandemic), and also observing the world around me in several countries both in Asia and Europe (admittedly not the US), with a variety of approaches to the pandemic, including regular conversations with frontline medical staff due to my work, this appears to be a fantastical claim.
2) You provided an image of a graph as evidence, with only vague indication of the source data, making it virtually impossible to verify.
3) I asked for a more compelling source to back up what I perceive to be a fantastical claim.
4) You responded by pivoting to US politics (which I know very little about and don't consider particularly relevant to the topic at hand) and ignored my request for more evidence.
Edit: I have only just noticed that the poster of the graph and the you are not one and the same person. I apologise for making that assumption. While it was thus not a "pivot", I still think the US politics angle is ad hominem.
I'm sure as fuck not getting an untested vaccine, because I'm not in a risk group. If I catch the virus, my risk of death is in lightning strike territory.
For my 70+ dad, he's in a bunch of risk groups, which means the risk equation looks very different for him, and for him it might be worth the risk of an untested vaccine.
Everyone has to do the risk calculation for themselves, and everyone is going to come to different conclusions. That's how it's supposed to work, and that's how it works for pretty much every other non-childhood vaccine.
there's two wrong concepts here - you don't know how the virus will affect you medically. May be you will only suffer minor symptoms, or may be you will almost die with fluids in your lungs.
But that's not important. The most important aspect of you catching the virus is you become a transmission vector. And you cause infection in other people who _do_ suffer from the symptoms. And you cause economic damage because people will need to lock down, or reduce economic activity.
Therefore, it's not a matter of just risk to themselves that is important in the calculus of vaccines. It's the over-all health risk of the society.
We do know the probabilities of those things, and for healthy non-elderly people the latter outcome is very unlikely.
I'm curious why you decided to bring up the fact that we can't predict, with certainty, in advance which will happen. We can't do that for any disease, many of which are as bad or much worse than Covid-19.
In no-good zombie-apocalypse Sweden, the total deaths/capita for 2020 is probably going to be above the 5-year average, but below the 10-year average and below the death rate of 2012.
Here's how the excess mortality of 2020 compares to the last 40 years of mortality in Germany, Sweden, France, and Belgium: https://medium.com/@FrankfurtZack/unprecedented-overall-mort...
If you didn't know about it, you wouldn't think anything special at all happened in 2020, just by looking at the statistics.
Right. And the flu deaths will be on top of the COVID deaths.
The number of dead due to covid-19 is not some kind of crazy anomaly that's going to stick out in the statistics.
Yes it is.
I don't know who @FrankfurtZack is beyond how he describes himself: "armchair virologist. hobbyvirologe, hobbystaatsepidemiologe". He has one post on Medium and that's it.
Here are some information sources that are more trustworthy.
https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm
https://www.nytimes.com/interactive/2020/08/12/us/covid-deat...
https://www.statnews.com/2020/08/03/measuring-excess-mortali... (Boston Globe)
https://www.economist.com/graphic-detail/2020/07/15/tracking...
The CDC link in particular is good because the first graph you come across when you scroll down shows deaths going back to 2017, so you can compare COVID excess deaths with H1N1 excess deaths.
Also, reputable link to the European data you refer to?
* What portion of the population will have reduced lung capacity post-COVID? How long will it last?
* What about other long-term effects, such as chronic fatigue? What puts me at risk? What causes it? How long does it last?
* What about other organ damage?
Please give me some semblance of an idea of what portion of the population will have long-term disability due to COVID?
That is, arguably, what makes this such a bonkers decision. Given that, around the world, production has started on phase 3 candidates, with no guarantee they'll ever be usable, skipping phase 3 doesn't really bring forward the time that a vaccine would see significant penetration. Doing so seems like a lot of risk for negligible benefit; it won't lead to saturation any quicker. And if anything goes wrong, the consequences, both immediate and in long-term damage to trust in the institutions, are potentially dramatic.
In fact, even if there are no negative medical effects, this could _still_ damage trust significantly. And raise significant ethical issues for medical professionals.
Really it's only the old people that should be given any kind of a COVID vaccine.
I didn't say anything about comparisons. I was pointing out that you were engaging in hyperbole.
Since in the end it's RISK of covid vs RISK of vaccine.
If you'd said something more nuanced I wouldn't be having this conversation.